A Retrospective Study on the Clinical Characteristics and Management of Immune-Related Adverse Events in Gynecologic Cancer Patients Treated with Immune Checkpoint Inhibitors.

[PURPOSE] This study aimed to characterize the clinical profile, risk factors, and management of immune-related adverse events (irAEs) in patients with gynecologic cancers treated with immune checkpoint inhibitors (ICIs).

[METHODS] In this single-center retrospective study, we analyzed data from 626 gynecologic cancer patients who received ICIs at our institution between January 2019 and July 2024. Data on the occurrence, grading, organ involvement, management, and potential risk factors of irAEs were collected and analyzed using binary logistic regression.

[RESULTS] Of the 626 patients, 136 (21.7%) developed irAEs. The most commonly affected systems were endocrine (11.7%), cardiac (3.2%), and skin (2.6%). The incidence of grade 1-2 and grade 3-4 irAEs was 17.7% and 3.99%, respectively. The median time to irAE onset was 9 weeks (after 3 treatment cycles). Binary logistic regression analysis revealed that anti-PD-1/CTLA-4 bispecific antibody was a significant risk factor for irAEs (OR = 2.874, p < 0.0001), whereas a higher number of treatment cycles and combination immunotherapy regimens were protective factors. Most irAEs were managed with intravenous methylprednisolone daily. No irAE-related deaths occurred.

[CONCLUSION] In this cohort of gynecologic cancer patients receiving ICIs, our findings suggest a considerable prevalence of endocrine and cardiac irAEs and identify several treatment-related factors associated with irAE risk. The results may underscore the potential importance of timely glucocorticoid initiation, and could support the consideration of empirical steroid therapy in critically ill patients when diagnostic confirmation is difficult. These findings point to the potential importance of organ-specific monitoring and provide insights that could inform the development of management strategies for this population.